Everything about the Health Insurance Portability and Accountability Act of 1996 (HIPAA), even its name, seems unwieldy and complex, especially for health tech startups. First time health tech entrepreneurs usually begin rethinking their life choices after we start discussing "covered entities" and "business associates," but in reality you can comply with the law relatively easily once you know the rules. That's why we built the HIPAA Check tool to help health tech entrepreneurs understand whether they need to comply with HIPAA and, if so, how to comply.
At its most basic level, HIPAA is designed to protect the privacy and security of patients by governing how entities that handle sensitive health information should protect that data, and it ensures patients are informed about how that data is used and stored. In order to be successful, health tech start ups must protect the privacy and security of patients, but for many companies it’s a constant struggle to figure out where they fit in under HIPAA.
Importantly, HIPAA rules do not apply to everyone who handles health related information. HIPAA only applies to health care providers and health plans (called “covered entities”) and certain organizations that perform activities on their behalf (called “business associates”).
Confused? You're not alone.
The slow-moving pace of government aside, the complexities within HIPAA often create more questions than answers, particularly for new technologies that didn’t exist when the guidelines were created 20 years ago.
While the government has recently issued additional guidance for mobile health companies and cloud service providers, many questions still go unanswered. Even basic questions like:
“Am I a business associate?”
“Can I be considered a conduit?”
“Can patients use my technology to text physicians?”
can be difficult to answer.
As we received more and more of these questions, two things became clear:
- The connected health community needs a clear and simple way to not only answer these key questions, but also to find the information they needed to navigate HIPAA and determine where they fit; and
- Those tools would also need to arm the connected health community with the information they needed to talk about HIPAA (and their obligations under HIPAA) with their customers, financiers, and users.
After about a year of trial, error, many meetings, and with the invaluable help of Joy Pritts, the former chief privacy officer for the Office of the National Coordinator at the U.S. Department of Health & Human Services, we created HIPAA Check. HIPAA Check is an interactive tool to help developers determine how their technology fits within the HIPAA framework. The tool takes each user through a series of questions with yes or no answers. Each question includes the definitions for terms they need, a video explaining the concept of “on behalf of,” and links to resources and places to find additional information.
Most importantly, once a user has completed HIPAA Check, they have the option of receiving a full report. The report provides all the questions answered and how they were answered. It also features reasoning for how they got the result they did, an overview of the entire tool, links to additional resources, and people they can contact if they have more questions.
While the information provided through the tool, and subsequently the report, should not be considered legal advice, the output of HIPAA Check will provide clarity for many companies as to their responsibilities under HIPAA. The report gives companies the documentation they need to show their prospective clients, users, and backers that they understand their role in protecting the privacy and security of patients utilizing technology to stay healthier.
If you’re working on a wearable or connected health apps/software, try out HIPAA Check. We think you’ll find it incredibly helpful, and please let us know if you have any questions or suggestions for how we can make it more useful to you and your company.